Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
278 participants
INTERVENTIONAL
2013-01-08
2017-06-20
Brief Summary
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Detailed Description
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* SCS group (SCS+OMM)
* OMM group
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SCS + OMM
Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan
Spinal Cord Stimulation (SCS)
Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.
Optimal Medical Management (OMM)
The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.
OMM alone
The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan
Optimal Medical Management (OMM)
The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.
Interventions
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Spinal Cord Stimulation (SCS)
Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.
Optimal Medical Management (OMM)
The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.
Eligibility Criteria
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Inclusion Criteria
* Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)
* Average low back pain is ≥ 5 as assessed by the baseline NPRS
* Average low back pain is greater than leg pain
* Subject has persistent moderate to severe low back and leg pain despite other treatments
Exclusion Criteria
* Most recent back surgery \< 6 months ago
* Low back pain only (no leg pain)
* Investigator suspects substance abuse that might confound the study results
* Radiographic evidence of instability requiring fusion
* Pain relieved completely by lying down
* Life expectancy of \< 24 months
* Subject is pregnant or planning to become pregnant during the course of the study
* Subject is unable to undergo study assessments or complete questionnaires independently
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe Rigoard, MD, PhD
Role: STUDY_CHAIR
University of Poitiers
Locations
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Pain Care LLC
Stockbridge, Georgia, United States
The Neuroscience Center
Ocean Springs, Mississippi, United States
Kozmary Center for Pain Management
Las Vegas, Nevada, United States
Albany Medical College
Albany, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
New York Spine and Wellness Center
North Syracuse, New York, United States
University of Rochester Neurosurgery Partners in Pain Management
Rochester, New York, United States
Duke Spine Center
Durham, North Carolina, United States
WellSpan Interventional Pain Center
York, Pennsylvania, United States
Richmond Bone and Joint Clinic
Sugar Land, Texas, United States
Utah Spine Care
Ogden, Utah, United States
West Virginia University
Morgantown, West Virginia, United States
UCL St. Luc
Brussels, , Belgium
AZ St. Maarten
Duffel, , Belgium
CHR Citadelle
Liège, , Belgium
Heilig Hart Ziekenhuis
Roeselare, , Belgium
Department of Neurosurgery: St. Augustinus Ziekenhuizen
Wilrijk, , Belgium
Regina General Hospital
Regina, , Canada
Clínica Las Américas
Medellín, Antioquia, Colombia
Hospital Pablo Tobón Uribe
Medellín, Antioquia, Colombia
San Vicente Fundación
Rionegro, Antioquia, Colombia
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Städtisches Klinikum Görlitz gGmbH
Görlitz, , Germany
St. Elisabeth Ziekenhuis Tilburg
Tilburg, , Netherlands
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Nottingham University Hospital NHS Trust
Nottingham, , United Kingdom
John Radcliffe Hospital Oxford
Oxford, , United Kingdom
Countries
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References
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O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
Rigoard P, Basu S, Desai M, Taylor R, Annemans L, Tan Y, Johnson MJ, Van den Abeele C, North R; PROMISE Study Group. Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial. Pain. 2019 Jun;160(6):1410-1420. doi: 10.1097/j.pain.0000000000001510.
Rigoard P, Desai MJ, North RB, Taylor RS, Annemans L, Greening C, Tan Y, Van den Abeele C, Shipley J, Kumar K. Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study). Trials. 2013 Nov 7;14:376. doi: 10.1186/1745-6215-14-376.
Other Identifiers
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1665
Identifier Type: -
Identifier Source: org_study_id
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